The IMF and the Euroflow Consortium Introduce Breakthrough in Detection of Minimal Residual Disease (MRD); Critical Element of Black Swan Research Initiative

-Automated, Highly Sensitive Test to Debut March 21-22 at International Workshop in Salamanca, Spain

-Could Lead to More Effective Treatment and a Shorter Path to New Drug Approvals

03.18.14

North Hollywood, CA, March 18, 2014 – The International Myeloma Foundation (IMF), in collaboration with the Europe-based EuroFlow consortium, will introduce a new automated and highly sensitive flow cytometry method for detecting minimal residual disease (MRD) in multiple myeloma at a workshop on March 21-22 in Salamanca, Spain.

The ability to measure MRD with extreme precision in myeloma patients is a critical tool for the IMF’s signature Black Swan Research Initiative®, launched in March 2013 to find a cure for myeloma. Immediately following the Spain workshop, on March 24th, an FDA panel will consider if the new method can be accepted as a new benchmark for MRD testing in myeloma.

“This new technique for measuring the myeloma cells that remain after treatment provides a much clearer framework for a cure,” said Dr. Brian G.M. Durie, IMF Chairman and Co-Founder. “This will allow us to select the most effective anti-MRD drug combinations for patient subgroups and it will also help guide the timing of myeloma treatment, determining whether early intervention, at onset or relapse, eradicates the most residual disease.”

Led by Dr. Durie and Dr. Alberto Orfao of the University of Salamanca, the two-day workshop at the Cancer Research Center at the University of Salamanca will include presentations by top myeloma researchers and will offer lab technicians from around the world hands-on training in the sophisticated new technology that will lead to more effective myeloma diagnosis and treatment, and more consistent results than are currently obtained.

Flow cytometry is a technique used widely in laboratories for counting and examining microscopic particles, such as cells and chromosomes, by suspending them in a stream of fluid and passing them through an electronic detection apparatus. However, the results can be plagued with inconsistencies. Using current methods, a blood sample can draw disparate readings depending upon who does the reading and/or where the test was done. A recent survey by the National Institutes of Health of flow cytometry labs at 30 major medical institutes in the US revealed widely divergent myeloma testing standards, with only 30% of the labs testing for MRD.

The flow cytometry method to be demonstrated at the upcoming IMF-EuroFlow workshop avoids these inconsistent and incomplete results, simplifying and optimizing the test using standardized algorithms, which “will really take out the subjectivity of the ‘experts,’” according to Dr. Orfao. It will also increase the sensitivity of the test—to 10-5 and below, which means an ability to detect as little as one myeloma cell in a million cells.

Dr. Durie added: “Without this technology to accurately measure MRD-ZeroTM in myeloma, the best patients could hope for was to reach complete remission (CR), then wait years for either nothing to happen or to relapse when hidden clones that had eluded treatment emerged.” Following the workshop, the IMF’s Black Swan Research Initiative investigators team will incorporate the new testing into continuing and future clinical trials.

ABOUT MYELOMA

Myeloma, also called multiple myeloma, is a cancer of cells in the bone marrow that affects production of red cells, white cells and stem cells and can damage bone. It is growing in numbers and affecting increasingly younger people.

ABOUT THE INTERNATIONAL MYELOMA FOUNDATION

Celebrating its 23nd anniversary, the International Myeloma Foundation reaches more than 350,000 members in 120 countries worldwide. A 501 (c) 3 non-profit organization dedicated to improving the quality of life of myeloma patients and their families, the IMF focuses on four key areas: research, education, support, and advocacy. To date, the IMF has conducted more than 250 educational seminars worldwide, maintains a world-renowned hotline, and established the International Myeloma Working Group (IMWG), a collaborative research initiative focused on improving myeloma treatment options for patients. The IMF can be reached at (800) 452-CURE (2873). The global website is www.myeloma.org.

The EuroFlow consortium consists of 17 diagnostic research groups and two associated SME's, which are regarded as experts in the fields of flow cytometric and molecular diagnostics. Together the 19 participants have sufficient complementarity and congruence to cover all aspects of development, standardization, and validation of highly sensitive tests for diagnosis and follow-up. EuroFlow is a division of the European Scientific foundation for Laboratory HematoOncology (ESLHO). For more information visit www.euroflow.org.